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NCT07880639Not yet recruiting

Incidence of Post TIPS/DIPS Heart Failure and the Factors Associated With Post-TIPS/DIPS Heart Failure.

Incidence of Post TIPS/DIPS Heart Failure and the Factors Associated With Post-TIPS/DIPS Heart Failure- A Single Center Prospective Cohort Study

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

The creation of a transjugular intrahepatic portosystemic shunt (TIPS) or direct intrahepatic portosystemic shunt (DIPS) results in an acute increase in venous return and cardiac preload. These procedures are established therapies for refractory ascites, variceal bleeding, hydrothorax, and Budd-Chiari syndrome, they may unmask subclinical cardiac dysfunction. Incidence of heart failure after TIPS varies widely from 0-25%, reflecting heterogeneity in patient selection and the lack of prospective data. Several predictors-including elevated pre-procedure BNP/NT-proBNP, diastolic dysfunction (E/e' \>10, LAVI \>34 mL/m²), impaired GLS, and elevated right-sided pressures-have been described, but most evidence arises from retrospective studies with inconsistent definitions.This single-center prospective cohort study at ILBS aims to determine the true incidence of heart failure within 6 months of TIPS/DIPS and to identify independent predictors using comprehensive clinical, biochemical, echocardiographic, and invasive hemodynamic parameters. Heart failure is a clinical syndrome with symptoms and/or signs caused by structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. In Echocardiography parameters GLS\<18 post TIPS for systolic function, E/e' average \> 15 for diastolic function will taken into consideration. In case of worsening diastolic function increase in grade of diastolic dysfunction ( measured by E/A)will be considered as post TIPS worsening.A total of 127 patients will be enrolled based on sample-size calculations assuming a 5% event rate. Findings will help create a clinically applicable predictive model to guide pre-TIPS cardiac risk stratification and optimize patient selection, thereby reducing morbidity and improving outcomes.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
127 (estimated)
First submitted
3 Mar 2026
Start date
27 Sept 2026
Primary completion date
28 Feb 2028
Lead sponsor
Institute of Liver and Biliary Sciences, India
NCT number
NCT07880639

What you commit to

  • Study type: Observational
  • Planned participants: 127
  • From 27 Sept 2026 to the primary completion date, 28 Feb 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients with no pre TIPS/DIPS Echocardiography
  • Patients with no pre TIPS/DIPS NT Pro BNP

Who the study is looking for

  • Age \> 18 years
  • All patients undergoing TIPS/DIPS

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Liver & Biliary Sciences (ILBS)
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.